GB 9706.239-2021

Active

Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

医用电气设备 第2-39部分:腹膜透析设备的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.20
CCS
C45
Status
Active
Issue Date
2021-08-10
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

GB 9706.239-2021 specifies particular safety and performance requirements for peritoneal dialysis equipment used in medical settings. It applies to devices that perform automated or continuous ambulatory peritoneal dialysis for patients with renal failure, covering aspects like fluid delivery, pressure monitoring, and alarm systems. This standard is used by manufacturers, testing laboratories, and healthcare facilities to ensure the equipment meets essential safety and performance criteria during clinical use.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.